BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 10C DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 179906 · Received July 29, 1998

    Report

    Report Number
    3015876-1998-00405
    Event Type
    Death
    Date Received
    July 29, 1998
    Date of Event
    July 2, 1998
    Report Date
    July 29, 1998
    Manufacturer
    PHYSIO-CONTROL CORPORATION
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A HELICOPTER TRANSPORT THE DEVICE WAS USED TO ADMINISTER EXTERNAL PACING TO PATIENT. AFTER APPROXIMATELY 10 MINUTES, PACING CURRENT DROPPED TO 0MA FOR NO APPARENT REASON. WHEN THE OPERATOR RESTARTED THE PACEMAKER, PACING FUNCTIONED BRIEFLY THEN THE PACER START/STOP LIGHT AGAIN EXTINGUISHED FOR NO APPARENT REASON AND PACING STOPPED. THIS ALLEGEDLY OCCURRED SEVERAL TIMES DURING THE TRANSPORT. THE PATIENT EXPIRED. THE HOSPITAL RISK MANAGER DID NOT KNOW IF THE ALLEGED MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10C DEFIBRILLATOR/MONITOR/PACEMAKER EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR/TRANSCUTANEOUS PAC LDD PHYSIO-CONTROL CORPORATION 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death QUIK-COMBO DEFIBRILLATION/PACING ELECTRODES.